Person who experienced the adverse event (patient)
| Event ID | CASEID | CASEVERSION | I F COD | EVENT DT | MFR DT | INIT FDA DT | FDA DT | REPT COD | AUTH NUM | MFR NUM | MFR SNDR | LIT REF | AGE | AGE COD | AGE GRP | GNDR COD | E SUB | WT | WT COD | REPT DT | TO MFR | OCCP COD | REPORTER COUNTRY | OCCR COUNTRY |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125531921 | 12553192 | 1 | I | 20160527 | 20160713 | 20160713 | EXP | US-MYLANLABS-2016M1022618 | MYLAN | KUTZLER HL, YE X, ROCHON C, MARTIN ST. ADMINISTRATION OF ANTITHYMOCYTE GLOBULIN (RABBIT) TO TREAT A SEVERE, MIXED REJECTION EPISODE IN A PREGNANT RENAL TRANSPLANT RECIPIENT. PHARMACOTHERAPY 2016;36(4):E18-E22. | 0.00 | Y | 0.00000 | 20160713 | OT | US | US |
Drug(s) used by person
| Event ID | CASEID | DRUG SEQ | ROLE COD | DRUGNAME | PROD AI | VAL VBM | ROUTE | DOSE VBM | CUM DOSE CHR | CUM DOSE UNIT | DECHAL | RECHAL | LOT NUM | EXP DT | NDA NUM | DOSE AMT | DOSE UNIT | DOSE FORM | DOSE FREQ |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 125531921 | 12553192 | 1 | PS | MYCOPHENOLATE MOFETIL. | MYCOPHENOLATE MOFETIL | 1 | Unknown | 1000 MG, BID | Y | 65520 | 1000 | MG | BID | ||||||
| 125531921 | 12553192 | 2 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 0 | |||||||||||
| 125531921 | 12553192 | 3 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 12 MG, BID | 0 | 12 | MG | BID | |||||||
| 125531921 | 12553192 | 4 | SS | TACROLIMUS. | TACROLIMUS | 1 | Unknown | 17 MG, BID | 0 | 17 | MG | BID | |||||||
| 125531921 | 12553192 | 5 | SS | AZATHIOPRINE. | AZATHIOPRINE | 1 | Unknown | 150 MG/DAY | 0 | ||||||||||
| 125531921 | 12553192 | 6 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 20 MG/DAY | 0 | ||||||||||
| 125531921 | 12553192 | 7 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 40 MG/DAY | 0 | ||||||||||
| 125531921 | 12553192 | 8 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 80 MG/DAY ON DAY 12 OF ADMISSION | 0 | ||||||||||
| 125531921 | 12553192 | 9 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 60 MG/DAY ON DAY 13 OF ADMISSION | 0 | ||||||||||
| 125531921 | 12553192 | 10 | SS | PREDNISONE. | PREDNISONE | 1 | Oral | 40 MG/DAY ON DAY14 | 0 | ||||||||||
| 125531921 | 12553192 | 11 | SS | PREDNISONE. | PREDNISONE | 1 | Unknown | 5 MG/DAY | 0 | ||||||||||
| 125531921 | 12553192 | 12 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 1G ON DAY 4 OF ADMISSION | U | U | 0 | ||||||||
| 125531921 | 12553192 | 13 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | ON DAY 5 OF ADMISSION | U | U | 0 | 500 | MG | ||||||
| 125531921 | 12553192 | 14 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 500MG ON DAY 6 OF ADMISSION | U | U | 0 | ||||||||
| 125531921 | 12553192 | 15 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Intravenous (not otherwise specified) | 125MG ON DAYS 7-11 | U | U | 0 | ||||||||
| 125531921 | 12553192 | 16 | SS | METHYLPREDNISOLONE. | METHYLPREDNISOLONE | 1 | Unknown | 500 MG ON ADMISSION 1 WEEK LATER | U | U | 0 | ||||||||
| 125531921 | 12553192 | 17 | SS | IMMUNE GLOBULIN | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 10G ON DAYS5, 7, 9, AND 11 OF ADMISSION | U | U | 0 | ||||||||
| 125531921 | 12553192 | 18 | SS | IMMUNE GLOBULIN | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 75G (1G/KG) ON DAY13, DAY14 | U | U | 0 | ||||||||
| 125531921 | 12553192 | 19 | SS | IMMUNE GLOBULIN | HUMAN IMMUNOGLOBULIN G | 1 | Intravenous (not otherwise specified) | 75MG ON ADMISSION 1 WEEK LATER | U | U | 0 | ||||||||
| 125531921 | 12553192 | 20 | SS | ANTITHYMOCYTE IMMUNOGLOBULIN (RABBIT) | LAPINE T-LYMPHOCYTE IMMUNE GLOBULIN | 1 | Unknown | 75MG (1MG/KG) ON DAYS6, 8, 10, AND 12 AFTER ADMISSION | U | U | 0 | ||||||||
| 125531921 | 12553192 | 21 | SS | VALGANCICLOVIR. | VALGANCICLOVIR | 1 | Unknown | U | U | 0 | 450 | MG | QOD | ||||||
| 125531921 | 12553192 | 22 | SS | ATOVAQUONE. | ATOVAQUONE | 1 | Unknown | 1500 MG/DAY | U | U | 0 | ||||||||
| 125531921 | 12553192 | 23 | SS | CLOTRIMAZOLE. | CLOTRIMAZOLE | 1 | Unknown | U | U | 0 | 10 | MG | BID |
Indications of drugs used
| Event ID | CASEID | INDI DRUG SEQ | INDI PT |
|---|---|---|---|
| 125531921 | 12553192 | 1 | Renal transplant |
| 125531921 | 12553192 | 2 | Immunosuppressant drug therapy |
| 125531921 | 12553192 | 5 | Immunosuppressant drug therapy |
| 125531921 | 12553192 | 6 | Immunosuppressant drug therapy |
| 125531921 | 12553192 | 12 | Immunosuppressant drug therapy |
| 125531921 | 12553192 | 17 | Immunosuppressant drug therapy |
| 125531921 | 12553192 | 20 | Immunosuppressant drug therapy |
| 125531921 | 12553192 | 21 | Antibiotic prophylaxis |
| 125531921 | 12553192 | 22 | Antibiotic prophylaxis |
| 125531921 | 12553192 | 23 | Antibiotic prophylaxis |
Outcome of event
| Event ID | CASEID | OUTC COD |
|---|---|---|
| 125531921 | 12553192 | OT |
Reactions reported
| Event ID | CASEID | DRUG REC ACT | PT |
|---|---|---|---|
| 125531921 | 12553192 | Foetal growth restriction | |
| 125531921 | 12553192 | Kidney transplant rejection | |
| 125531921 | 12553192 | Maternal exposure during pregnancy | |
| 125531921 | 12553192 | Treatment noncompliance |
Reporting Sources (this data is often not reported and may therefore be missing here)
| no results found |
Therapies reported
| Event ID | CASEID | DSG DRUG SEQ | START DT | END DT | DUR | DUR COD |
|---|---|---|---|---|---|---|
| 125531921 | 12553192 | 1 | 20130806 | 20141020 | 0 |